Healthcare Industry News: vascular access
News Release - April 20, 2010
AngioDynamics Announces First Patient Treatment and Ongoing Enrollment in the Clinical Trial of the Use of IRE Technology in the Treatment of Early Stage Primary Liver CancerSeven Medical Centers in Europe to Participate in Clinical Trial
QUEENSBURY, N.Y.--(HSMN NewsFeed)--AngioDynamics (NASDAQ:ANGO ) today announced the first patient treatment and growing enrollment in a pilot study of the use of the Company’s NanoKnife® Irreversible Electroporation (IRE) System in the treatment of early stage hepatocellular carcinoma (HCC), or primary liver cancer. This clinical trial is being conducted under the supervision of Professor Jordi Bruix of the Barcelona Clinic Liver Cancer Group of the University of Barcelona and Professor Riccardo Lencioni of the University of Pisa School of Medicine.
The purpose of the clinical trial is to study the safety and efficacy of IRE in the treatment of early stage liver cancer. While patient enrollment is underway in Pisa, the clinical trial has been initiated at three other sites including two medical centers in Germany and one in Spain. AngioDynamics plans that, in total, seven centers will participate in the study.
“The first patient treatment and ongoing enrollment in the HCC study represent important milestones in the Company’s Irreversible Electroporation development program,” said Jan Keltjens, AngioDynamics President and CEO. “Our strategy with NanoKnife is to proceed carefully and methodically to build a body of evidence that demonstrates the clinical efficacy and safety of this system for the treatment of specific cancers.”
Updates on the status of the study, titled “A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC),” can be found at www.clinicaltrials.gov.
As of March 31, 2010, physicians have treated a total of 154 patients in 11 centers around the world, utilizing the NanoKnife IRE System. Procedures have been performed on many different organs, including prostate, liver, lung and pancreas.
AngioDynamics is a leading provider of innovative medical devices used by interventional radiologists, surgeons and other physicians for the minimally-invasive treatment of cancer and peripheral vascular disease. The Company’s diverse product line includes market-leading radiofrequency and irreversible electroporation ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.AngioDynamics.com.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “potential,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to develop its existing and new products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, results of pending litigation, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to execute its leadership development plan and integrate purchased businesses, as well as the risk factors listed from time to time in the SEC filings of AngioDynamics, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2009. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.
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